Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea (Korea HM3 PMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 358
- 试验地点
- 29
- 主要终点
- Primary Efficacy Endpoint: Number of participants with overall survival to transplant, myocardial recovery or on device support free of debilitating stroke (60 days post-stroke Modified Rankin Score >3) or reoperation for pump replacement
研究概览
简要总结
The Korea HM3 PMS is a prospective, single arm, open-label, multi-center, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will enroll up to 300 patients, that meet the Health Insurance Review and Assessment (HIRA) guidelines for LVAD implantation, from up to 25 sites in South Korea. Subjects who will be implanted but not included in the PMS can be enrolled retrospectively after obtaining their informed consent. The surveillance period for this PMS is expected to be 4 years from the time of HM3 approval in Korea, concluding on June 2, 2024.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria: All patients approved for HM3 implantation in Korea as per HIRA guidelines will be eligible to be enrolled in the PMS. Only the patients who provide written informed consent will be included in the study. If a subject has had an outcome after the HM3 implantation but prior to providing informed consent, no consent will be obtained, and a limited anonymized data will be collected.
排除标准
- •This post market surveillance does not have specific exclusion criteria
研究组 & 干预措施
HeartMate 3™ left ventricular assist system (HM3 LVAS)
Patients will be implanted with the HM3 LVAS
干预措施: HeartMate 3™ left ventricular assist system (HM3 LVAS) (Device)
结局指标
主要结局
Primary Efficacy Endpoint: Number of participants with overall survival to transplant, myocardial recovery or on device support free of debilitating stroke (60 days post-stroke Modified Rankin Score >3) or reoperation for pump replacement
时间窗: Throughout the study (approximately 4 years)
Overall survival to transplant, myocardial recovery or on device support free of debilitating stroke (60 days post-stroke Modified Rankin Score \>3) or reoperation for pump replacement will be assessed using the Kaplan-Meier product-limit method along with a competing outcomes graph. Subjects who are urgently transplanted due to a HeartMate 3 malfunction will be considered to have experienced a primary endpoint event, as will subjects who expire, suffer a debilitating stroke or have their HeartMate 3 exchanged due to a device failure. Subjects who are transplanted (except as described above), explanted for recovery, withdraw from the trial or are lost to follow-up will be censored at that time in the analysis.
Primary Safety Endpoint: Number of cumulative occurrence of adverse events
时间窗: Throughout the study (approximately 4 years)
Cumulative occurrence of adverse events will be presented as percent of patients with adverse events and events per patient year of support.
Primary Efficacy Endpoint: Kaplan-Meier Success Rate of Overall Survival to Transplant, Myocardial Recovery or on Device Support Free of Debilitating Stroke (60 Days Post-stroke Modified Rankin Score >3) or Reoperation for Pump Replacement
时间窗: From enrollment to 36 months
Overall survival to transplant, myocardial recovery or on device support free of debilitating stroke (60 days post-stroke Modified Rankin Score \>3) or reoperation for pump replacement. Subjects who are urgently transplanted due to a HeartMate 3 malfunction will be considered to have experienced a primary endpoint event, as will subjects who expire, suffer a debilitating stroke or have their HeartMate 3 exchanged due to a device failure. Subjects who are transplanted (except as described above), explanted for recovery, withdraw from the trial or are lost to follow-up will not be considered to have experienced a primary endpoint event.
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events
时间窗: From enrollment until the study conclusion date (up to 43 months, 3 days)
Cumulative occurrence of adverse events will be presented as percent of patients with adverse events.
次要结局
- Mean change in Six-minute Walk Test from baseline(Through study completion, an average of 4 years)
- Change in proportion of New York Heart Association (NYHA) Functional Status from baseline(Through study completion, an average of 4 years)
- Mean change in EQ-5D-5L quality of life (QoL) from baseline(Through study completion, an average of 4 years)
- Number of participants with Device Malfunctions(Throughout the study (approximately 4 years))
- Frequency of Rehospitalization and Reoperation(Throughout the study (approximately 4 years))
- Incidence of adverse events including, but not limited to, neurological dysfunction, bleeding, infections and device thrombosis.(Throughout the study (approximately 4 years))
- Six-minute Walk Test Distance(Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months post-implant)
- New York Heart Association (NYHA) Functional Status(Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months post-implant)
- EQ-5D-5L Quality-of-Life Visual Analog Scale(Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months Post-Implant)
- Frequency of Rehospitalization(From enrollment until the study conclusion date (up to 43 months, 3 days))
- Frequency of Reoperation(From enrollment until the study conclusion date (up to 43 months, 3 days))
- Device Malfunctions(From enrollment until the study conclusion date (up to 43 months, 3 days))